跳至主要内容
临床试验/NCT02086981
NCT02086981已完成不适用

The DETEcT Study - Delirium in Elderly paTiEnts Admitted to Trauma

Azienda Ospedaliero-Universitaria Careggi1 个研究点 分布在 1 个国家目标入组 672 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
672
试验地点
1
主要终点
Prevalence of Delirium, its association with risk factors and their prognostic value

研究概览

简要总结

Primary objectives are to define incidence and prevalence of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and, in the postoperative phase, in the high Dependency Unit as well as to determine the presence of risk factors. Secondary objectives are to determine mean hospital stay, rates of complications as well as in-hospital mortality and at 1-3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 moths follow-up.

详细描述

The aging of population as well as the increased life expectancy put progressively urgent demands about the adequacy of the level of care provided in a hospital environment to ensure clinical pathways tailored on the needs of each individual patient. On the other hand, the gradual evolution of Health Care systems to care for the acute, with increasing levels of specialization often technologically driven, cannot and must not neglect these aspects of personalization of care protecting the elderly "frail" patient, because of its intrinsic characteristics. In such a context, evaluation of frailty undertakes not only the meaning of prevention and promotion of quality of life but it takes in account important issues for patient's safety and the economic weight it entails. Delirium (acute confusional state) is a complex syndrome which frequently occurs in the elderly hospitalized population. Development of Delirium is associated with negative outcomes such as a longer hospital stay, a higher rate of complications, cognitive and functional decline, loss of independence, institutionalization, and, ultimately, death. For skilled healthcare professionals, on the other hand, it represents a challenging condition because a prompt and accurate diagnosis with the introduction of all those prevention and non-pharmacological measures may reduce the incidence, severity and/or duration of Delirium and improve functional recovery. Therefore the meaning of conducting such an observational study is also to provide evidence of patients' needs and address the on-ground educational aspect for healthcare professionals in a daily practice. The purposes of the study are to determine the incidence and prevalence (before and after surgery) of Delirium in an elderly population admitted to the Department of Orthopedics and Traumatology and in the High Dependency Unit in the postoperative phase as well as to determine the risk factors for developing such a condition. Secondary objectives are mean hospital stay, rates of complications as well as in-hospital mortality and at 1, 3 and 12 months after discharge, functional recovery and cognitive outcomes at 1, 3 and 12 months follow-up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with any medical condition with an age of 65 years and older

排除标准

  • Impossibility to give an informed consent; refusal

结局指标

主要结局

Prevalence of Delirium, its association with risk factors and their prognostic value

时间窗: At hospital admission

Patients are evaluated on admission with: * IqCode * Katz Index of Independence in Activities of Daily Living (ADL) * The Lawton Instrumental Activities of Daily Living (IADL) Scale * The Barthel Index for Mobility * The Confusion Assessment Method (CAM) * The 4AT Scale * Presence of Risk Factors

Incidence of Delirium, its association with risk factors and their prognostic value

时间窗: After surgery and for the next 48 hours

Detection of any change in clinical condition. Patients are evaluated with: * The Confusion Assessment Method (CAM) * The 4AT Scale

次要结局

  • Mortality rates(At 1,3 and 12 months follow-up)
  • Changes in functional capabilities(At 1, 3 and 12 months follow-up)
  • Mean Hospital Stay(In-Hospital)
  • Clinical Complications(In-Hospital)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alessandro Cartei, MD

Medicina Interna per la Gestione Pre e Postoperatoria Traumatologica e del Percorso Neuromotorio

Azienda Ospedaliero-Universitaria Careggi

研究点 (1)

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